Onealfa combined with Predonine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Thrombocytopenic Purpura Other Serious 4/7/2006 8 Female 4/28/2006 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 2/29/2004 Female 121 lb 6/30/2006 Physician Japan
Primary
Secondary
Concomitant
Tuberculous Pleurisy Life Threatening 5/13/2006 Female 97 lb 7/7/2006 Physician Japan
Primary
Secondary
Hypoglycaemia Other Serious 1/24/2006 Male 119 lb 7/7/2006 Physician Japan
Primary
Concomitant
Tuberculous Pleurisy Life Threatening 5/13/2006 Female 97 lb 8/1/2006 Physician Japan
Primary
Secondary
Tuberculous Pleurisy Life Threatening 5/13/2006 Female 97 lb 8/7/2006 Physician Japan
Primary
Secondary
Upper Respiratory Tract Inflammation Hospitalization 1/23/2004 Female 119 lb 8/21/2006 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 1/24/2006 Male 119 lb 8/24/2006 Physician Japan
Primary
Secondary
Concomitant
Tuberculous Pleurisy Life Threatening 5/13/2006 Female 97 lb 9/13/2006 Physician Japan
Primary
Secondary
Rash Hospitalization 7/7/2006 50 Female 9/20/2006 Physician Japan
Primary
Concomitant
Rash Hospitalization 7/7/2006 50 Female 10/4/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombosis Hospitalization 9/22/2006 32 Female 11/30/2006 Consumer United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/7/2006 56 Female 90 lb 12/12/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 1/23/2004 Female 119 lb 12/14/2006 Physician Japan
Primary
Secondary
Concomitant
Myasthenia Gravis Other Serious 10/1/2006 80 Male 99 lb 12/29/2006 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 12/6/2006 Male 144 lb 1/4/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/1/2004 Female 121 lb 2/14/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 12/18/2006 30 Female 2/19/2007 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 1/24/2006 Male 119 lb 2/20/2007 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/6/2006 Male 144 lb 3/1/2007 Physician Japan
Primary
Secondary
Concomitant
Depressed Level Of Consciousness Hospitalization 2/12/2007 16 Female 3/12/2007 Physician Japan
Primary
Secondary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 3/16/2007 Physician Japan
Primary
Secondary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 3/23/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 2/26/2007 Female 95 lb 4/13/2007 Physician Japan
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Other Serious 3/9/2007 75 Male 4/23/2007 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 1/23/2004 Female 119 lb 5/1/2007 Physician Japan
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Life Threatening 3/9/2007 75 Male 117 lb 5/2/2007 Physician Japan
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Life Threatening 3/9/2007 75 Male 117 lb 5/24/2007 Physician Japan
Primary
Secondary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 5/25/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 3/3/2007 28 Female 127 lb 5/30/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 12/13/2006 30 Female 6/6/2007 Physician Japan
Primary
Secondary
Concomitant
Appendicitis Hospitalization 2/15/2007 Female 99 lb 6/18/2007 Physician Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 11/1/2005 Female 99 lb 6/19/2007 Physician Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 7/7/2006 50 Female 6/25/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 11/1/2005 Female 99 lb 7/5/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 3/1/2004 Female 121 lb 7/5/2007 Physician Japan
Primary
Secondary
Concomitant
Anaphylactoid Reaction Other Serious 6/1/2007 Male 64 lb 7/13/2007 Physician Japan
Primary
Concomitant
Anaphylactoid Reaction Other Serious 1/6/2007 Male 64 lb 10/22/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/7/2006 56 Female 90 lb 10/24/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 7/7/2006 50 Female 11/2/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 3/3/2007 Female 127 lb 10/26/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 10/4/2007 71 Female 115 lb 11/13/2007 Physician Japan
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 12/8/2007 67 Female 12/19/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 10/4/2007 71 Female 115 lb 12/19/2007 Physician Japan
Primary
Concomitant
Rheumatoid Factor Positive Disability 1/1/2007 42 Female 1/3/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 12/8/2007 66 Female 106 lb 1/7/2008 Physician Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 2/15/2007 Female 99 lb 1/14/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 10/4/2007 71 Female 115 lb 1/29/2008 Physician Japan
Primary
Concomitant
Hypoglycaemia Other Serious 1/24/2006 Male 119 lb 5/22/2008 Physician Japan
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Life Threatening 7/24/2007 Male 119 lb 5/22/2008 Physician Japan
Primary
Concomitant
Hypoglycaemia Other Serious 1/24/2006 Male 119 lb 6/23/2008 Physician Japan
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Life Threatening 7/24/2007 Male 119 lb 6/23/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 4/15/2008 7/7/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumomediastinum Other Serious 6/1/2007 Male 7/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumomediastinum Other Serious 6/1/2007 Male 7/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumomediastinum Other Serious 6/1/2007 Male 7/31/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumomediastinum Other Serious 6/1/2007 Male 8/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 2/15/2007 Female 99 lb 10/3/2008 Physician Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 10/20/2008 70 Female 10/23/2008 Pharmacist
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 10/20/2008 70 Female 10/31/2008 Physician
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 7/5/2004 Male 11/7/2008 Other Health Professional Japan
Primary
Concomitant
Urinary Retention Other Serious 1/1/2008 90 11/26/2008 Pharmacist Japan
Primary
Concomitant
Ventricular Fibrillation Life Threatening 7/5/2004 Male 11/27/2008 Other Health Professional Japan
Primary
Concomitant
Urine Output Decreased 1/1/2008 90 12/5/2008 Pharmacist Japan
Primary
Concomitant
Renal Disorder Hospitalization 7/16/2008 Female 143 lb 2/23/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/16/2009 65 Female 4/13/2009 Physician
Primary
Secondary
Concomitant
Death Death 9/13/2007 Female 4/14/2009 Physician Japan
Primary
Concomitant
Perihepatic Abscess Hospitalization 3/16/2009 67 Female 137 lb 4/20/2009 Physician Japan
Primary
Secondary
Concomitant
Perihepatic Abscess Death 3/16/2009 67 Female 137 lb 4/29/2009 Physician Japan
Primary
Secondary
Concomitant
Blood Bilirubin Increased Death 9/13/2007 Female 90 lb 5/26/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 8/6/2008 Male 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Speech Disorder Other Serious 6/2/2009 Female 79 lb 9/23/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Hyperhidrosis Hospitalization 53 9/30/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 6/2/2009 Female 79 lb 10/15/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 3/3/2007 Female 127 lb 11/30/2009 Physician Japan
Primary
Concomitant
Speech Disorder Hospitalization 6/2/2009 Female 79 lb 12/18/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 12/29/2009 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 1/4/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/17/2009 Female 75 lb 1/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Hospitalization 9/19/2009 Male 139 lb 1/12/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 1/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Death Death 1/27/2010 Pharmacist Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/1/2009 Male 126 lb 1/28/2010 Physician Japan
Primary
Secondary
Concomitant
Death Death 1/29/2010 Pharmacist Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 2/1/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 2/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Staphylococcal Hospitalization 9/19/2009 Male 139 lb 2/19/2010 Physician Japan
Primary
Secondary
Concomitant
Subcutaneous Abscess Other Serious 10/16/2009 Female 2/25/2010 Other Health Professional Japan
Primary
Concomitant
Vomiting Other Serious 2/22/2010 Female 3/5/2010 Physician Japan
Primary
Concomitant
Dyspnoea Exertional Hospitalization 1/13/2010 67 Female 98 lb 3/19/2010 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 10/20/2009 56 Male 3/23/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 5/3/2006 38 Male 157 lb 4/6/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/21/2009 71 Female 126 lb 4/7/2010 Physician Switzerland
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Hypertension Other Serious 10/21/2009 54 Female 152 lb 4/13/2010 Physician Japan
Primary
Concomitant
Herpes Zoster Hospitalization 10/24/2008 78 Female 123 lb 4/13/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 4/15/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/21/2009 71 Female 126 lb 4/21/2010 Physician Switzerland
Primary
Concomitant
Pruritus Hospitalization 5/3/2006 38 Male 157 lb 4/23/2010 Physician Japan
Primary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 4/23/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Femur Fracture Other Serious 10/23/2005 75 Female 4/23/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 3/26/2010 79 Male 121 lb 4/30/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 106 lb 5/6/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/21/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/21/2009 71 Female 126 lb 6/7/2010 Physician Switzerland
Primary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 7/1/2009 54 Male 119 lb 6/11/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 6/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Hypertension Other Serious 10/21/2009 54 Female 152 lb 6/22/2010 Physician Japan
Primary
Concomitant
Haemoptysis Death 6/8/2010 69 Male 126 lb 7/7/2010 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 10/24/2008 78 Female 123 lb 7/8/2010 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 3/19/2009 51 Female 110 lb 7/9/2010 Physician Japan
Primary
Concomitant
Hypoglycaemia Life Threatening 3/26/2010 79 Male 121 lb 7/9/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Other Serious 7/1/2009 54 Male 119 lb 7/12/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/6/2009 74 Male 126 lb 7/15/2010 Physician Japan
Primary
Secondary
Concomitant
Urticaria Hospitalization 5/10/2010 29 Female 130 lb 7/20/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 5/17/2010 86 Female 7/20/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 5/17/2010 86 Female 7/20/2010 Physician Japan
Primary
Concomitant
Haemoptysis Death 6/8/2010 69 Male 126 lb 7/22/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 2/22/2010 66 Female 7/29/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 2/22/2010 66 Female 119 lb 7/30/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/27/2010 70 Female 8/5/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 83 Female 106 lb 8/6/2010 Physician Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 2/22/2010 66 Female 119 lb 8/30/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 83 Female 106 lb 9/1/2010 Physician Japan
Primary
Concomitant
Haemoptysis Death 3/1/2010 69 Male 126 lb 9/3/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/11/2010 68 Female 101 lb 9/13/2010 Physician Japan
Primary
Concomitant
Leukopenia Hospitalization 10/20/2009 56 Male 9/17/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 8/11/2010 67 Female 101 lb 9/20/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 83 Female 106 lb 9/28/2010 Physician Japan
Primary
Concomitant
Bronchopulmonary Aspergillosis Death 4/22/2010 69 Male 126 lb 10/5/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 3/19/2009 51 Female 110 lb 10/8/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 3/5/2009 85 Male 108 lb 10/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 5/3/2006 38 Male 157 lb 10/20/2010 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 6/12/2010 60 Male 130 lb 12/20/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Death 3/5/2009 85 Male 108 lb 1/4/2011 Physician Japan
Primary
Secondary
Concomitant
Joint Arthroplasty Hospitalization 9/22/2008 30 Female 88 lb 1/31/2011 Physician Japan
Primary
Concomitant
Pneumonia Staphylococcal Life Threatening 8/26/2006 58 Male 143 lb 2/11/2011 Physician Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 8/1/2006 58 Male 143 lb 2/15/2011 Physician Japan
Primary
Secondary
Concomitant
Aortic Dissection Other Serious 10/12/2010 80 Female 75 lb 2/23/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/10/2009 71 Female 106 lb 2/28/2011 Physician Japan
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 47 Female 3/2/2011 Consumer Japan
Primary
Concomitant
Hepatic Function Abnormal 11/10/2009 71 Female 106 lb 3/9/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 2/24/2011 67 Female 3/14/2011 Other Health Professional Japan
Primary
Concomitant
Hyponatraemia Hospitalization 2/24/2011 67 Female 3/16/2011 Physician Japan
Primary
Concomitant
Hydrocephalus Hospitalization 2/24/2011 67 Female 3/28/2011 Other Health Professional Japan
Primary
Concomitant
Pneumonia Staphylococcal Life Threatening 8/1/2006 58 Male 143 lb 4/6/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/6/2009 74 Male 126 lb 4/12/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data